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Machine Learning-Guided LIV Selection for Adolescent Idiopathic Scoliosis

19 juli 2026 bijgewerkt door: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

A Prospective Randomized Controlled Trial of the Drum Tower Rule Machine Learning Model for Lowest Instrumented Vertebra Selection in Lenke Type 1 and Type 5 Adolescent Idiopathic Scoliosis

This study will evaluate whether a machine learning-based decision support model, called the Drum Tower Rule, can help surgeons select the lowest instrumented vertebra during corrective surgery for adolescent idiopathic scoliosis.

Patients with Lenke type 1 or Lenke type 5 adolescent idiopathic scoliosis who are scheduled for posterior spinal fusion will be randomly assigned to one of two groups. In the model-guided group, surgeons will receive the model-predicted risk of postoperative distal adding-on and a recommendation for lowest instrumented vertebra selection. In the conventional-experience group, surgeons will select the lowest instrumented vertebra according to routine clinical experience and existing surgical principles, without access to the model output.

All patients will receive standard posterior spinal fusion. The main outcome is the incidence of distal adding-on at 24 months after surgery, assessed by blinded radiographic reviewers.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Adolescent idiopathic scoliosis is a common spinal deformity in children and adolescents. For patients requiring corrective surgery, selection of the lowest instrumented vertebra is a key surgical decision. An inappropriate distal fusion level may increase the risk of postoperative distal adding-on, coronal imbalance, unnecessary loss of spinal mobility, or revision surgery.

The Drum Tower Rule is a machine learning-based decision support model developed to estimate the risk of postoperative distal adding-on and assist with lowest instrumented vertebra selection in patients with Lenke type 1 and Lenke type 5 adolescent idiopathic scoliosis. Before the start of this trial, the model, input variables, risk threshold, and software version will be locked and will not be modified during the study.

This is a single-center, prospective, randomized, open-label, parallel-group controlled trial with blinded outcome assessment. Eligible participants will be randomly assigned in a 1:1 ratio to either the model-guided group or the conventional-experience group. Randomization will be stratified by Lenke classification.

In the model-guided group, preoperative clinical and radiographic variables will be entered into the locked machine learning model. The model will generate a predicted risk of distal adding-on and a recommendation for lowest instrumented vertebra selection. For Lenke type 1 patients, the decision will focus on selection between one level proximal to the last substantially touching vertebra and the last substantially touching vertebra. For Lenke type 5 patients, the decision will focus on selection between L3 and L4. The surgeon will make the final decision after considering the model output and clinical judgment.

In the conventional-experience group, the surgeon will select the lowest instrumented vertebra based on routine clinical experience and existing surgical principles. The model output will not be provided to the surgeon for participants in this group.

Both groups will undergo standard posterior spinal fusion with an all-pedicle screw instrumentation system. Postoperative follow-up will be performed at 1 week and at 3, 6, 12, and 24 months after surgery. The primary outcome is the incidence of distal adding-on at 24 months after surgery. Secondary outcomes include number of fused segments, Cobb angle correction rate, coronal balance, sagittal radiographic parameters, Scoliosis Research Society-22 score, visual analog scale score for low back pain, complications, instrumentation failure, revision surgery, and adoption of model recommendations.

The primary outcome will be assessed by independent radiographic reviewers who are blinded to treatment allocation.

Studietype

Ingrijpend

Inschrijving (Geschat)

300

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Xiaodong Qin, MD, PhD
  • Telefoonnummer: 025-68182923
  • E-mail: gyethics@163.com

Studie Locaties

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Diagnosis of adolescent idiopathic scoliosis classified as Lenke type 1A or Lenke type 5C.
  • Age 10 to 18 years, inclusive.
  • Scheduled to undergo posterior spinal fusion using an all-pedicle screw instrumentation system.
  • Planned selective thoracic fusion or selective lumbar fusion, with a clinical need for lowest instrumented vertebra decision-making.
  • Availability of required preoperative standing full-spine radiographs and bending radiographs.
  • Ability and willingness to complete the planned 24-month postoperative follow-up.
  • Written informed consent provided by the participant and legal guardian.

Exclusion Criteria:

  • - Congenital scoliosis, neuromuscular scoliosis, syndromic scoliosis, or other non-idiopathic scoliosis.
  • History of spinal trauma, spinal tumor, spinal tuberculosis, or spinal infection.
  • Previous spinal surgery.
  • Severe sagittal spinal deformity, such as Scheuermann disease, for which the study model is not applicable.
  • Neurological symptoms or signs.
  • Leg length discrepancy greater than 10 mm.
  • The surgeon determines that there is no clinical equipoise for lowest instrumented vertebra selection because one option is clearly contraindicated for safety or anatomical reasons.
  • Inability to complete follow-up or required study assessments.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Model-Guided Group
Participants in this group will undergo standard posterior spinal fusion. Before surgery, preoperative clinical and radiographic variables will be entered into the locked Drum Tower Rule machine learning model. The model will generate a predicted risk of distal adding-on and a recommendation for lowest instrumented vertebra selection. The surgeon will make the final decision after considering the model output and clinical judgment.
Ander: Drum Tower Rule Machine Learning-Guided Decision Support
A locked machine learning-based decision support model will be used before surgery to estimate the risk of postoperative distal adding-on and provide a recommendation for lowest instrumented vertebra selection. The model output will be available to surgeons in the model-guided group only.
Procedure: Posterior Spinal Fusion
All participants will undergo standard posterior spinal fusion using an all-pedicle screw instrumentation system.
Actieve vergelijker: Conventional-Experience Group
Participants in this group will undergo standard posterior spinal fusion. The surgeon will select the lowest instrumented vertebra according to routine clinical experience and existing surgical principles. The Drum Tower Rule model output will not be provided to the surgeon for participants in this group.
Procedure: Posterior Spinal Fusion
All participants will undergo standard posterior spinal fusion using an all-pedicle screw instrumentation system.
Ander: Conventional LIV Decision-Making
The lowest instrumented vertebra will be selected by the surgeon according to routine clinical experience and existing surgical principles, without access to the Drum Tower Rule model output.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Distal Adding-on
Tijdsspanne: 24 months after surgery
Distal adding-on is defined as an increase of more than 5 degrees in the disc angle below the lowest instrumented vertebra compared with the immediate postoperative radiograph, or an increase of more than 5 mm in the translation of the vertebra below the lowest instrumented vertebra relative to the central sacral vertical line. The outcome will be assessed by blinded radiographic reviewers.
24 months after surgery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Scoliosis Research Society-22 Score
Tijdsspanne: 24 months after surgery
Health-related quality of life will be assessed using the Scoliosis Research Society-22 questionnaire.
24 months after surgery

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Surgery-Related Complications
Tijdsspanne: From surgery to 24 months after surgery
Surgery-related complications include perioperative complications, instrumentation failure, proximal junctional kyphosis, adjacent segment degeneration, pseudarthrosis, infection, and revision surgery.
From surgery to 24 months after surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 juni 2027

Studie voltooiing (Geschat)

1 september 2030

Studieregistratiedata

Eerst ingediend

19 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

19 juli 2026

Eerst geplaatst (Werkelijk)

23 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

19 juli 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • NDTH-20260578

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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